Clinical Trials 2010;7:58-68. [doi: 10.1177/1740774509356575]
Viviana E. Horigian, MD (University of Miami Miller School of Medicine, FNA Node), Michael S. Robbins, PhD (University of Miami Miller School of Medicine, FNA Node), Roberto Dominguez, PhD (University of Miami Miller School of Medicine, FNA Node), Jessica Ucha (University of Miami Miller School of Medicine, FNA Node), Carmen L. Rosa, MS (Center for the Clinical Trials Network, NIDA).
Behavioral intervention research has lagged behind biomedical research in developing principles for defining, categorizing, identifying, reporting, and monitoring adverse events and unanticipated problems. In this article, a set of principles for defining adverse events are presented, along with how they were applied in the National Drug Abuse Treatment Clinical Trials Network multi-site family therapy study for substance-using adolescents, protocol CTN-0014, the Brief Strategic Family Therapy (BSFTTM) for Adolescent Drug Abusers study. This study tested how BSFTTM compares to treatment as usual (TAU) for the treatment of drug-abusing adolescents. During protocol development, experts in the BSFTTM intervention, medical safety officers, ethicists, and senior investigators defined the procedures for identifying, tracking, and reporting adverse events for drug using adolescents as well as their family members. During this process, the team identified five key guiding principles: that the adverse events should be validated and plausible and that monitoring systems should assess relatedness, be systematic, and be a shared responsibility. Non-serious adverse events included arrest, school suspension and drop-out, runaway, kicked out of home, and violence. Serious adverse events included physical or sexual abuse, suicidal behavior, homicidal behavior, hospitalization (drug-related or psychiatric only), and death. More than 50% of the adolescent population experienced an adverse event during the trial. Family members experienced fewer (4.5%). The most common event for the adolescent group was arrest, followed by school suspension/drop-out. For the family member group, the most common event was violence, followed by arrest. There was a significant difference in the presence of adverse events in family members that were randomized to BSFTTM (6.1%) when compared to TAU (2.8%). One probable explanation for this is that there were more opportunities to identify adverse events for family members assigned to BSFTTM because family members attended therapy sessions. The safety plan of the BSFTTM study has important implications for future studies with drug using adolescents and family-based interventions, though as these principles were developed specific to the issues and challenges faced in this single protocol, the application of the principles in designing procedures for defining and tracking adverse events in research on other behavioral interventions or clinical populations may be limited. Safety data in the BSFTTM trial support the principles that founded the BSFTTM safety plan, and illustrate the importance of safety monitoring in behavioral intervention research. (Article (Peer-Reviewed), PDF, English, 2010)
Keywords: Adolescents | Adverse events | Behavior therapy | Brief Strategic Family Therapy (BSFT) | CTN platform/ancillary study | CTN protocol development | Family therapy | Research design | Clinical Trials (journal)
Document No: 572, PMID: 20156957, PMCID: PMC3163837.
Submitted by the CTN Dissemination Librarians, 12/29/2010.